For US healthcare professionals only

OMLYCLO is the first and only FDA-approved biosimilar interchangeable with Xolair®1,2

What is a

BIOSIMILAR?3

A biosimilar is a biologic medication that is highly similar to an existing FDA-approved biologic, or reference product

There are no clinically meaningful differences from the reference product in safety, purity, or potency

An FDA-approved biosimilar is expected to have the same treatment benefits and risks as the reference product

What is an

INTERCHANGEABLE BIOSIMILAR?4

An interchangeable biosimilar must first meet the FDA standard for biosimilarity and then satisfy additional requirements for interchangeability

The FDA also evaluates switching between the interchangeable biosimilar and the reference product to confirm no greater risk in safety or reduced effectiveness than continued use of the reference product alone

Subject to state pharmacy laws, an interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber

To learn more about biosimilars and interchangeability, visit the FDA’s Overview for Health Care Professionals.

The FDA has determined that OMLYCLO can produce the same clinical result as the reference product in any given patient.1

How the FDA evaluates biosimilars across indications

The FDA may approve a biosimilar across multiple reference-product indications through scientific extrapolation.3

What is

EXTRAPOLATION?3

When a biosimilar is approved for one disease, the FDA may allow it to be used for other indications approved for the reference product, without requiring separate clinical trials for each. However, the biosimilars manufacturer must provide scientific justification for those additional indications. This is called extrapolation.

OMLYCLO has been established as biosimilar across all approved Xolair indications.1

How does

EXTRAPOLATION take place?3

STEP 1:

Demonstrate biosimilarity in a sensitive setting through a comparative clinical study designed to detect potential product differences.

STEP 2:

Confirm similarity beyond clinical response through FDA review of analytical similarity, PK/PD, immunogenicity, and safety versus the reference product.

STEP 3:

Extend approval to other reference product indications when scientifically justified, based on evidence supporting similar performance across conditions of use and patient populations.

Through the totality of evidence supporting biosimilarity, OMLYCLO is expected to provide the same safety and efficacy as Xolair across its approved indications, including labeled pediatric populations.1,3

Batch-to-batch variation is standard across biologics3

Minor batch-to-batch variation is expected with biologics, including reference products such as Xolair. Because biologics are made in living cells, each batch may contain slight, naturally occurring variations.

These variations are tightly controlled through predefined quality specifications and ongoing lot-by-lot monitoring of critical quality attributes.

OMLYCLO was evaluated within this same biologic framework and approved by the FDA as highly similar to Xolair, with no clinically meaningful differences in safety, purity, or potency.

Explore OMLYCLO Efficacy Data

CRSwNP, chronic rhinosinusitis with nasal polyps; CSU, chronic spontaneous urticaria;
PD, pharmacodynamics; PK, pharmacokinetics.

References: 1. OMLYCLO Prescribing Information. Celltrion USA, Inc.; 2025. 2. US Food and Drug Administration. BLA approval letter 761399 for OMLYCLO. Published March 7, 2025. 3. US Food and Drug Administration. Biosimilar Product Regulatory Review and Approval. Accessed March 17, 2026. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf 4. US Food and Drug Administration. Biosimilars Info Sheet Level 1. Accessed May 5, 2026. https://www.fda.gov/media/154911/download

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration. Healthcare providers administering OMLYCLO should be prepared to manage anaphylaxis, which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis.

Contraindications:

Severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO.

Anaphylaxis. Life-threatening anaphylaxis has occurred after omalizumab products, with signs/symptoms including bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue; it can occur as early as the first dose, beyond 1 year after starting, and has been reported up to 4 days after administration. Initiate OMLYCLO in a healthcare setting equipped to manage anaphylaxis and observe patients for an appropriate period after dosing; educate patients on signs/symptoms and the need for immediate medical care. Risk is increased in patients with a history of anaphylaxis to foods, medications, or other causes. After therapy is safely established, self-administration OMLYCLO prefilled syringe may be appropriate for selected patients/caregivers based on risk mitigation (including no prior history of anaphylaxis, at least 3 supervised doses without hypersensitivity, ability to recognize and appropriately treat anaphylaxis, and ability to perform SC injections correctly). Discontinue OMLYCLO in patients who experience a severe hypersensitivity reaction.

Malignancy. Malignant neoplasms have been observed in clinical studies; the impact of longer exposure and use in patients at higher baseline risk is not known, and limitations of longer-term observational data preclude definitively ruling out a malignancy risk with omalizumab products.

Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to relieve acute asthma exacerbations; do not use OMLYCLO to treat acute bronchospasm or status asthmaticus. Advise patients to seek medical care if asthma remains uncontrolled or worsens after starting OMLYCLO.

Corticosteroid Reduction. Do not abruptly discontinue systemic or inhaled corticosteroids when starting OMLYCLO for asthma or CRSwNP; taper gradually under physician supervision. In CSU patients, use of omalizumab products in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions. In rare cases, patients with asthma on omalizumab products have developed serious systemic eosinophilia, sometimes with vasculitis consistent with Churg-Strauss syndrome, often in the setting of oral corticosteroid reduction. Be alert for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy; a causal association has not been established.

Fever, Arthralgia, and Rash. In post-approval use, a serum sickness-like constellation (arthritis/arthralgia, rash, fever, lymphadenopathy) has occurred 1 to 5 days after injections and may recur with additional doses; stop OMLYCLO if this constellation develops.

Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection during OMLYCLO therapy; available data are insufficient to define the duration of monitoring needed after stopping treatment. A clinical trial in a high-risk setting observed more infections with omalizumab than placebo; response to appropriate anti-geohelminth treatment was not different between groups.

Laboratory Tests. Total serum IgE increases after dosing and may remain elevated for up to 1 year after discontinuation due to drug-IgE complexes; do not use total IgE levels obtained less than 1 year after discontinuation to reassess dosing regimen for asthma, CRSwNP, or IgE-mediated food allergy because these levels may not reflect steady-state free IgE levels.

Potential Medication Error Related to Emergency Treatment of Anaphylaxis. OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis. Instruct patients that OMLYCLO is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.

Most Common Adverse Reactions:

  • Asthma: In patients ≥12 years, reported in ≥1%: arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In pediatric patients (6 to <12 years), reported in ≥3%: nasopharyngitis, headache, pyrexia, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.
  • CRSwNP: In ≥3% of adults: headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness.
  • IgE-Mediated Food Allergy: In ≥3% of patients: injection site reactions and pyrexia.
  • CSU: In ≥2% of patients: nausea, nasopharyngitis, sinusitis, upper respiratory tract infections (viral and non-viral), arthralgia, headache, and cough.

INDICATIONS

OMLYCLO® (omalizumab-igec) injection is an anti-IgE antibody indicated for:

  • Moderate to severe persistent asthma in adults and pediatric patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids.
  • Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients ≥18 years of age with inadequate response to nasal corticosteroids, as add-on maintenance treatment.
  • IgE-mediated food allergy in adult and pediatric patients ≥1 year of age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance.
  • Chronic spontaneous urticaria (CSU) in adults and adolescents ≥12 years of age who remain symptomatic despite H1 antihistamine treatment.

Limitations of Use: Not indicated for acute bronchospasm or status asthmaticus; emergency treatment of allergic reactions, including anaphylaxis; and other forms of urticaria.

Please see the full Prescribing Information for complete details. To report suspected adverse reactions, contact CELLTRION USA, INC. at 1‑800‑560‑9414 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate OMLYCLO therapy in a healthcare setting and closely observe patients for an appropriate period of time after OMLYCLO administration. Healthcare providers administering OMLYCLO should be prepared to manage anaphylaxis, which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of OMLYCLO should be based on criteria to mitigate risk from anaphylaxis.

Contraindications:

Severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO.

Anaphylaxis. Life-threatening anaphylaxis has occurred after omalizumab products, with signs/symptoms including bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue; it can occur as early as the first dose, beyond 1 year after starting, and has been reported up to 4 days after administration. Initiate OMLYCLO in a healthcare setting equipped to manage anaphylaxis and observe patients for an appropriate period after dosing; educate patients on signs/symptoms and the need for immediate medical care. Risk is increased in patients with a history of anaphylaxis to foods, medications, or other causes. After therapy is safely established, self-administration OMLYCLO prefilled syringe may be appropriate for selected patients/caregivers based on risk mitigation (including no prior history of anaphylaxis, at least 3 supervised doses without hypersensitivity, ability to recognize and appropriately treat anaphylaxis, and ability to perform SC injections correctly). Discontinue OMLYCLO in patients who experience a severe hypersensitivity reaction.

Malignancy. Malignant neoplasms have been observed in clinical studies; the impact of longer exposure and use in patients at higher baseline risk is not known, and limitations of longer-term observational data preclude definitively ruling out a malignancy risk with omalizumab products.

Acute Asthma Symptoms and Deteriorating Disease. Omalizumab products have not been shown to relieve acute asthma exacerbations; do not use OMLYCLO to treat acute bronchospasm or status asthmaticus. Advise patients to seek medical care if asthma remains uncontrolled or worsens after starting OMLYCLO.

Corticosteroid Reduction. Do not abruptly discontinue systemic or inhaled corticosteroids when starting OMLYCLO for asthma or CRSwNP; taper gradually under physician supervision. In CSU patients, use of omalizumab products in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions. In rare cases, patients with asthma on omalizumab products have developed serious systemic eosinophilia, sometimes with vasculitis consistent with Churg-Strauss syndrome, often in the setting of oral corticosteroid reduction. Be alert for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy; a causal association has not been established.

Fever, Arthralgia, and Rash. In post-approval use, a serum sickness-like constellation (arthritis/arthralgia, rash, fever, lymphadenopathy) has occurred 1 to 5 days after injections and may recur with additional doses; stop OMLYCLO if this constellation develops.

Parasitic (Helminth) Infection. Monitor patients at high risk of geohelminth infection during OMLYCLO therapy; available data are insufficient to define the duration of monitoring needed after stopping treatment. A clinical trial in a high-risk setting observed more infections with omalizumab than placebo; response to appropriate anti-geohelminth treatment was not different between groups.

Laboratory Tests. Total serum IgE increases after dosing and may remain elevated for up to 1 year after discontinuation due to drug-IgE complexes; do not use total IgE levels obtained less than 1 year after discontinuation to reassess dosing regimen for asthma, CRSwNP, or IgE-mediated food allergy because these levels may not reflect steady-state free IgE levels.

Potential Medication Error Related to Emergency Treatment of Anaphylaxis. OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis. Instruct patients that OMLYCLO is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.

Most Common Adverse Reactions:

  • Asthma: In patients ≥12 years, reported in ≥1%: arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In pediatric patients (6 to <12 years), reported in ≥3%: nasopharyngitis, headache, pyrexia, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.
  • CRSwNP: In ≥3% of adults: headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness.
  • IgE-Mediated Food Allergy: In ≥3% of patients: injection site reactions and pyrexia.
  • CSU: In ≥2% of patients: nausea, nasopharyngitis, sinusitis, upper respiratory tract infections (viral and non-viral), arthralgia, headache, and cough.

INDICATIONS

OMLYCLO® (omalizumab-igec) injection is an anti-IgE antibody indicated for:

  • Moderate to severe persistent asthma in adults and pediatric patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids.
  • Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients ≥18 years of age with inadequate response to nasal corticosteroids, as add-on maintenance treatment.
  • IgE-mediated food allergy in adult and pediatric patients ≥1 year of age for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance.
  • Chronic spontaneous urticaria (CSU) in adults and adolescents ≥12 years of age who remain symptomatic despite H1 antihistamine treatment.

Limitations of Use: Not indicated for acute bronchospasm or status asthmaticus; emergency treatment of allergic reactions, including anaphylaxis; and other forms of urticaria.

Please see the full Prescribing Information for complete details. To report suspected adverse reactions, contact CELLTRION USA, INC. at 1‑800‑560‑9414 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.